Balloon testing device

ABSTRACT

A device for testing an elongated elastic sleeve or balloon. The device has a pair of clamp members which selectively grip opposed ends of the sleeve, and the device inflates the sleeve while retained by the clamp members. The device illuminates the inflated sleeve walls from the inside of the sleeve to permit visual inspection of the sleeve walls. The device also permits rotation of the clamp members and retained sleeve to permit visual inspection of the inflated sleeve walls circumferentially around the sleeve. The device permits submersion of the inflated sleeve into a testing liquid in order to determine whether the sleeve walls leak.

BACKGROUND OF THE INVENTION

The present invention relates to testing devices, and more particularlyto devices for testing an elongated elastic sleeve or balloon.

A various assortment of catheters have been proposed in the past for usein patients. Many of such catheters, for example Foley catheters andendotracheal tubes, are constructed with an inflatable sleeve or balloonon a shaft to permit retention or sealing by the balloon in thepatient's body. For example, Foley catheters are normally constructedhaving an elongated hollow shaft defining a drainage lumen, aninflatable sleeve secured on a distal end of the shaft, and a drainageeye adjacent the distal end of the shaft communicating with the drainagelumen. The catheter shaft is passed through the patient's urethra untilthe drainage eye and inflatable sleeve are located in the bladder, and adrainage tube is connected to a proximal end of the catheter shaft whichis located outside the patient's body. The sleeve is inflated through asidearm and inflation lumen of the catheter in order to expand theballoon in the patient's bladder, and retain the catheter in place.During catheterization, urine drains from the bladder through thedrainage eye, the drainage lumen, and the drainage tube to a collectionbag for retention therein.

The inflatable balloons or sleeves are normally constructed from arelatively thin elastic material, such as silicone, which may be formedby extrusion. It is not uncommon that the sleeves may containimperfections, such as areas of weakness or pin holes, whichdeleteriously affect operation of the catheter balloon during use. Forexample, if the catheter balloon contains one or more pin holes, theballoon may deflate in the patient's body, thus rendering the catheterballoon useless. In some instances, the defective balloon may beundetected by the physician, and may result in possible harm to thepatient. Thus, it is necessary to assure that the catheter balloon is inan acceptable condition before supplying the catheter to the physician.

In the past, catheter balloons have been tested pursuant to manufactureby individually inflating each of the balloons after securement onto thecatheter shaft. It will be apparent that this procedure is both timeconsuming and tedious, and necessarily adds to the manufacturing cost ofthe catheter. Moreover, such tests merely ascertain that the balloon maybe inflated, and may not reveal more serious defects in the balloonwhich are not apparent during inflation. For example, the balloon mayhave an area of weakness which may rupture during use, particularly whenstresses are applied to the inflated balloon, or the balloon may haveone or more relatively small pin holes which leak slowly during anextended period of time. Further, even if a defect in the balloon isdiscovered by this procedure, the balloon has been previously securedonto the catheter shaft, and the entire catheter must be discarded dueto the faulty balloon, thus unnecessarily resulting in waste andadditional cost to the manufacturing procedures.

SUMMARY OF THE INVENTION

A principal feature of the present invention is the provision of adevice for testing an elongated elastic sleeve.

The device of the present invention comprises, an elongated inflationmember to receive one end of the sleeve, with the inflation memberhaving an orifice communicating with the inside of the sleeve when thesleeve is placed on the inflation member and having a passagewaycommunicating with the orifice. The device has a first clamp memberhaving a pair of opposed movable jaws on opposed sides of the inflationmember. The device has means for selectively moving the jaws of thefirst clamp member between a first open position with the jaws spacedfrom the inflation member, and a second closed position with the jawsgripping the sleeve against the inflation member. The device has anelongated illumination member to receive the other end of the sleeve,and a second clamp member having a pair of opposed movable jaws onopposed sides of the illumination member. The device has second meansfor selectively moving the jaws of the second clamp member between afirst open position with the jaws spaced from the illumination member,and a second closed position with the jaws gripping the sleeve againstthe illumination member.

A feature of the invention is that the operator may place one end of thesleeve over the inflation member and then initiate operation of thedevice.

Another feature of the invention is that the device assures that theoperator's hands are removed from the movable portion of the apparatusfor safety purposes.

Still another feature of the invention is that after initiation of thedevice, the first clamp member automatically closes and grips the oneend of the sleeve against the inflation member.

Yet another feature of the invention is that the device automaticallyadvances the illumination member into the other end of the sleeve, andthen closes the second clamp member against the other sleeve end overthe illumination member.

A further feature of the invention is that the device then automaticallyinflates the retained sleeve with a predetermined amount of air.

Yet another feature of the invention is the provision of means formodifying the amount of predetermined air which is utilized to inflatethe sleeve.

Still another feature of the invention is that a source of light isconnected to the illumination member, such that the illumination memberilluminates the walls of the inflated sleeve from the inside of thesleeve.

Thus, a feature of the invention is that the sleeve walls areautomatically illuminated from the inside in order to permit clearvisual inspection of the sleeve walls while expanded.

Yet another feature of the invention is that the inflated sleeve may berotated while being illuminated to visually inspect the sleeve wallscircumferentially around the sleeve.

Still another feature of the invention is that the inflated sleeve maybe submerged into a testing liquid in order to determine whether airpasses through the walls of the inflated sleeve as indicated by risingair bubbles in the liquid.

A feature of the invention is that the operator may signal the apparatusafter testing has been completed, and the device automatically releasesthe tested sleeve from the first and second clamp members after whichthe operator may retain or discard the sleeve depending upon the testingresults.

Yet another feature of the invention is the provision of means formaintaining a total count of acceptable and defective sleeves over aperiod of prolonged testing of numerous sleeves by an operator.

Thus, a feature of the present invention is that the sleeves may betested in a simplified and efficient manner.

A further feature of the invention is that the testing device ascertainsimperfections in the sleeve which would otherwise be undetected.

Yet another feature of the invention is that the device permits testingof the sleeves prior to securement onto a catheter shaft, and eliminatesthe waste associated with disposal of entire catheters having defectiveballoons.

A further feature of the invention is that the device reduces theeffective manufacturing cost of the catheters.

Still another feature of the invention is that the device minimizes thepossibility that a catheter having a defective balloon may be suppliedto the physician for use.

Further features will become more fully apparent in the followingdescription of the embodiments of this invention and from the appendedclaims.

DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a fragmentary front elevational view, taken partly in section,of a balloon testing apparatus of the present invention;

FIG. 2 is a fragmentary end elevational view, partly broken away, of theballoon testing apparatus of the present invention;

FIG. 3 is a sectional view taken substantially as indicated along theline 3--3 of FIG. 1;

FIG. 4 is a fragmentary end view of an inflation clamp member in an openconfiguration taken substantially as indicated along the line 4--4 ofFIG. 1;

FIG. 5 is a fragmentary end view of the clamp member of FIG. 4illustrating the clamp member in a closed configuration;

FIG. 6 is a fragmentary end view of an illumination clamp member of theapparatus of FIG. 1 illustrating the clamp member in an openconfiguration;

FIG. 7 is a fragmentary elevational view, taken partly in section, ofdriving mechanism for the apparatus of FIG. 1;

FIG. 8 is a diagrammatic view of the balloon testing apparatus of thepresent invention;

FIG. 9 is a perspective view of a typical inflatable balloon which maybe tested by the apparatus of the present invention;

FIG. 10 is a diagrammatic view illustrating the balloon of FIG. 9 in aninflated configuration during testing; and

FIG. 11 is a schematic view of a control system for the device.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to FIG. 1, there is shown an apparatus generallydesignated 20 for testing an inflatable balloon. As shown in FIG. 9, theballoon comprises an annular sleeve 22 defining a channel 24, and havinga pair of opposed ends 26. Typically, such a balloon or sleeve 22 may beextruded from a suitable material, such as silicone. The balloon may beconstructed of desired diameter, length, and thickness for use on anysuitable catheter, such as a Foley catheter or an endotracheal tube. Theopposed ends 26 of the sleeve 22 are secured onto a catheter shaftduring manufacture of the catheter, such that the sleeve 22 defines acavity between the sleeve and the shaft. During use, the sleeve isinflated through a lumen which communicates with the cavity beneath thesleeve. In the case of a Foley catheter, the sleeve is inflated in thepatient's bladder in order to retain the catheter in proper positiononce it has been placed. It is not uncommon that the sleeves may containimperfections, such as regions of weakness or pin holes, subsequent toformation. Although the balloon may be inflated for testing purposesafter it has been secured to the catheter shaft, the entire cathetermust be discarded if the balloon should prove defective. Accordingly, itis desirable to test the balloon prior to securement onto the cathetershaft. As will be described below, the apparatus of the presentinvention accomplishes this result in an efficient and simplified mannerwhile greatly enhancing the detection of defective balloons.

With reference to FIG. 1, the apparatus 20 has a power switch 28, and aplurality of control switches, such as a pair of spaced switches 30labelled "Start", a switch 32 labelled "Reject", and a switch 34labelled "Accept". The apparatus 20 may also have a pair of digitalcounters 36 and 38, with the counter 36 being associated with the rejectswitch 32 and being labelled "Reject", and with the switch 38 beingassociated with the accept switch 34 and being labelled "Accept". Theoperation of the above switches and counters in association with thecontrol system for the apparatus will be described in detail below. Asshown, the apparatus 20 may also have a suitable tray 40 defining acavity 42 to receive a testing liquid L.

With reference to FIGS. 1 and 2, the apparatus 20 has a test assemblygenerally designated 44 having a pair of spaced and generally alignedfirst and second support members 46 and 48. The second support member 48has an upright arm 50, and a hollow support arm 52 extending forwardlyfrom an upper end 54 of the arm 50, and being inclined downwardly fromthe upper end 54 at an acute angle relative to the upright arm 50. Thefirst support member 46 is aligned with the second support member 48 andhas a configuration very similar to the second support member 48. Thus,the first support member 46 has an upright arm 56, and a forwardlyprojecting hollow support arm 58 extending at an acute angle from anupper end 60 of the arm 56 in a manner as previously described inconnection with the second support member 48. As viewed in FIG. 2, theupright arms 50 and 56 and the support arms 52 and 58 of the supportmembers 48 and 46, respectively, are aligned with each other along thelength of the test assembly 44. The desired alignment between thesupport members 46 and 48 is permanently maintained by an elongatedshaft 62 which is received in the upper ends 54 and 60 of the respectivesupport members 48 and 46. The shaft 62 may be fixedly mounted in theupper end 60 of the first support member 46, while the shaft 62 isslidable received in a suitable bearing 64 mounted in the upper end 54of the second support member 48 in order to permit modification of thespacing between the first and second support members 46 and 48.

As shown in FIGS. 1 and 2, the test assembly 44 has an elongated crankshaft 66 which is rotatably mounted by suitable bearings in the opposedwalls of the support arm 52 associated with the second support member48. Similarly, the test assembly 44 has an elongated crank member 68which is rotatably mounted by suitable bearings in the opposed walls ofthe support arm 58 associated with the first support member 46. Asshown, the crank member 68 has an elongated hollow sleeve 70 which isdirected toward the crank shaft 66, with an outer end 72 of the shaft 66being slidably received in the crank member sleeve 70. The sleeve 70 hasan elongated slot 74 which receives an outwardly directed pin 76 on theouter end 72 of the crank shaft 66. A handle or crank member 78 isattached to the opposed end of the shaft 66, such that the operator mayimpart rotational movement to the crank shaft 66. In turn, the pin 76 onthe shaft 66 engages against the wall of the sleeve 70 defining the slot74 in order that rotational movement of the shaft 66 is translated tothe sleeve 70 and the crank member 68 in the first support member 46.Further, the shaft pin 76 may move longitudinally in the sleeve slot 74while the shaft 66 slides in the sleeve 70 in order that the relativespacing between the first and second support members 46 and 48 may bemodified.

The test assembly 44 has an inflation clamp member 80 which is mountedon an air connection member 82 having a central portion 84 which extendsthrough and which is rotatably mounted in a lower end 86 of the supportarm 58 associated with the first support member 46. In this regard,rotational movement of the air connection member 82 in the support arm58 is imparted to rotational movement of the inflation clamp member 80about a central axis. The test assembly 44 also has an illuminationclamp member 88 which is mounted on a light transmitting member 90. Acentral portion 92 of the transmitting member 90 is rotatably mounted ina lower end 94 of the support arm 52 associated with the second supportmember 48, such that rotational movement of the light transmittingmember 90 is imparted to rotational movement of the clamp member 88.

With reference to FIGS. 1 and 2, the crankshaft 66 has a sprocket 96with suitable teeth 98 positioned within the support arm 52 associatedwith the second support member 48. Also, the transmitting member 90 hasa sprocket 100 with suitable teeth 102 positioned within the lower end94 of the support arm 52. As shown, the second support member 48 alsohas a suitable endless chain or belt 104 passing around the sprockets 96and 100, with the associated teeth 98 and 102 being received in thechain 104. In addition, the crank member 68 has a suitable sprocket withteeth positioned in the support arm 58 associated with the first supportmember 46, while the connection member 82 has a suitable sprocket withteeth positioned within the lower end 86 of the support arm 58, with anendless chain passing around the sprockets associated with the crankmember 68 and the connection member 82. It will be appreciated that thesprocket and chain assembly in the support arm 58 associated with thefirst support member 46 is virtually identical to the sprocket and chainassembly in the support arm 52 associated with the second support member48.

Thus, when the handle 78 is turned by the operator, rotation of thecrank shaft 66 is translated through the chain 104 to rotationalmovement of the light transmitting member 90 and the associatedillumination clamp member 88. In addition, as previously discussed,rotation of the crank shaft 66 is imparted to the crank member 68through the cooperating pin 76 and slot 74 associated respectively withthe crank shaft 66 and the crank member 68. In turn, rotation of thecrank member 68 is imparted through the chain in the support arm 58 tothe air connection member 82 and associated inflation clamp member 80.Accordingly, the described apparatus translates rotational movement ofthe handle 78 to simultaneous rotation of the inflation clamp member 80and the illumination clamp member 88, with the device being constructedsuch that the clamp members 80 and 88 rotate the same angle relativeeach other responsive to a given rotation of the handle 78 and shaft 66.In this manner, the operator may readily rotate the clamp members 80 and88 through use of the handle 78 for a purpose which will be describedbelow.

With reference to FIG. 1, the apparatus 20 has an air supply line 106which communicates through a suitable passageway to an actuating nozzle108 having an orifice 110. Further, the air connection member 82 has asuitable passageway extending between a valve assembly 112 at one end ofthe connection member 82 through the connection member 82 to aninflation nozzle 114 which projects from a central portion of the clampmember 80 at the other end of the connection member 82, with the nozzle114 having a passageway communicating with an orifice 116 at the outerend of the nozzle 114. The valve assembly 112 has an elastic O-ring 118defining a seat, and a ball 120 which is biased by a helical spring 122against the O-ring 118 in a chamber 124 of the valve assembly 112. Thevalve chamber 124 communicates through the passageway with the inflationnozzle 114, and the valve assembly 112 is normally closed, such that theend of the passageway associated with the valve assembly 112 is normallyclosed from the atmosphere. In a normal configuration of the connectionmember 82, the valve assembly 112 is aligned with and slightly spacedfrom the actuation nozzle 108. In this configuration, the device permitsrotational movement of the connection member 82 and the clamp member 80in the support arm 58 without obstruction between the valve assembly 112and the actuation nozzle 108.

As will be further discussed below, the first support member 46 may bemoved by the apparatus in a direction toward the left, as viewed in FIG.1, such that the connection member 82 and the valve assembly 112 areadvanced toward the actuation nozzle 108 until the nozzle 108 contactsthe ball 120 through an opening 126 in the valve assembly 112, such thatthe nozzle 108 moves the ball 120 away from the O-ring 118 and opens thevalve assembly 112 while the O-ring sealingly engages against theoutside of the nozzle 108. The apparatus has an arm 128 supporting ahollow sleeve 130 which slidably receives a conduit member 132 defininga passageway between the supply line 106 and the nozzle 108 whichprojects outwardly from the conduit member 132. As shown, a helicalspring 134 extends around a portion of the conduit member 132 and biasesa flange 136 of the conduit member 132 away from a flange 138 on thesleeve 130. In this manner, the conduit member 132 is biased by thespring 134 in a direction toward the valve assembly 112, such that theconduit member 132 is permitted to yield and slide in the sleeve 130when struck by the valve assembly 112 on the connection member 82. Atthe same time, the nozzle 108 on the conduit member 132 opens the valveassembly 112 in order to establish communication between the passagewayin the conduit member 132 and the passageway in the connection member82. As will be further discussed below, a predetermined amount of air isthen passed from the supply line 106 through the passageway in theconduit member 132, the valve assembly 112, the passageway in theconnection member 82, and the nozzle 114 into the elastic sleeve whichis retained on the clamps 80 and 88 in order to inflate the sleeve.After the predetermined amount of air has been utilized to inflate thesleeve, the apparatus moves the first support member 46 in a directiontowards the right, as viewed in FIG. 1, in order to withdraw theactuation nozzle 108 from the valve assembly 112. Thus, the valveassembly 112 closes at this time in order to maintain the balloon in aninflated condition for purposes of testing. Further, in thisconfiguration, the valve assembly 112 is spaced from the actuationnozzle 108 to prevent obstruction between the nozzle 108 and the valveassembly 112 during rotation of the connection member 82 as will befurther described below.

With reference to FIG. 1 and 8, the apparatus 20 has a suitable lightsource 140 which is connected to an elongated flexible lighttransmitting conduit 142 in the transmitting member 90. In turn, theconduit 142 extends through the lower end 94 of the support arm 52 andthrough a central portion of the clamp member 88, with the transmittingconduit 142 being connected to an elongated illumination member 144which projects from the clamp member 88. The light transmitting conduit142 may comprise a suitable bundle of fiber optics strands, such as asuitable glass or lucite. The illumination member 144 may be constructedfrom a durable material, e.g., a polycarbonate material sold under thetrademark Lexan by the General Electric Company. Thus, the devicetransmits light from the light source 140 through the conduit 142 to theillumination member 144 in order to illuminate the inflated balloon bythe illumination member 144 from the inside through the walls of theballoon.

With reference to FIGS. 1 and 4, the inflation clamp member 80 has apair of opposed jaws 146a and 146b which are slidably received on a pairof spaced bolts 148a and 148b which pass through suitable pairs ofspaced bores 150a and 150b extending through the respective jaws 146aand b. The bolts 148a and b have associated heads 152a and 152b whichengage against a lower surface 154 of the lower jaw 146b. The otherthreaded ends 156a and 156b of the bolts 148a and b are received insuitable threaded apertures 158a and 158b in a plate 160 which isconnected to a lower end 162 of an air cylinder 164. As shown, thecylinder 164 has a piston 166 which projects from the cylinder 164 andengages against an upper surface 168 of the upper jaw 146a. The clampmember 80 has a pair of internal springs which biases the lower jaw 146btowards the respective heads 152a and b of the bolts 148a and b, andwhich biases the upper jaw 146a towards the plate 160 and against thecylinder piston 166.

As previously discussed, the connection member 82 extends through theclamp member 80 intermediate the opposed jaws 146a and b with theinflation nozzle 114 projecting from the jaws, as shown in FIG. 1. Withreference to FIG. 4, the jaws 146a and b have opposed elastic retainingmembers 170a and 170b which may be made from a suitable material, suchas rubber. As shown, the retaining members 170a and b have associatedrecesses 172a and 172b which face towards the inflation nozzle 114, suchthat the retaining members 170a and b engage against the inflationnozzle 114 around the recesses 172a and b when the clamp member 80 isclosed. Further, the retaining members 170a and b have slightly raisedsemi-annular gripping portions 174a and 174b which are snugly receivedwithin an annular recess of the inflation nozzle 114 when the clampmember 80 is closed. The annular recess of the inflation nozzle 114 isvirtually identical to the recess which will be described below inconnection with the illumination member 144 associated with the clampmember 88.

With reference to FIGS. 1 and 5, when the cylinder 164 is actuated, thepiston 166 extends from the cylinder 164 and bears against the uppersurface 168 of the upper jaw 146a. In turn, the plate 160 is moved awayfrom the upper jaw 146a, such that the plate 160 moves the bolts 148aand b through the jaws 146a and b while the bolt heads 152a and b engageagainst the lower surface 154 of the lower jaw 146b. Thus, the piston166 and bolts 148a and b cooperate to bring the jaws 146a and b into aclosure position while the retaining members 170a and b snugly engageagainst the inflation nozzle 114. When the piston 166 subsequentlyretracts into the cylinder 164, the springs in the clamp member 80 biasthe jaws 146a and b from the closure position illustrated in FIG. 5 tothe open position illustrated in FIGS. 1 and 4. As will be furtherdescribed below, one end of the elastic sleeve is placed over theinflation nozzle 114 with the clamp member 80 open preparatory totesting, and the device then actuates the cylinder 164 to extend thepiston 166 and close the jaws 146a and b, such that the respectiveretaining members 170a and b grip the sleeve in sealing engagement aboutthe inflation nozzle 114. After the other end of the sleeve has beensuitably engaged by the jaws of the other clamp member 88 in sealingengagement, air is passed through the inflation nozzle 114 into thesleeve in order to inflate the balloon and permit testing.

The illumination clamp member 88 illustrated in FIG. 1 is shown ingreater detail in FIG. 6. As will be apparent, the structure of theclamp member 88 is very similar to the structure of the clamp member 80,and, for convenience, reference numerals associated with parts of theclamp 88 which are similar to the parts previously discussed for theclamp member 80 will be utilized with the addition of a prime ('). Thus,with reference to FIGS. 1 and 6, the clamp member 88 has a pair ofopposed jaws 146a' and 146b' which are slidably received on a pair ofbolts 148a' and 148b', and which are biased outwardly by springs to anopen position of the jaws 146a' and 146b' and the clamp member 88. Thejaws 146a' and 146b' have associated elastic retaining members 170a' and170b' which face toward the illumination member 144 of the lighttransmitting member 90 which extends through the clamp member 88intermediate the jaws 146a' and 146b'. As shown, the illumination member144 has a tapered outer end 176 to spread light within the inflatedsleeve, and an annular recess 178 which is aligned with the opposedelastic retaining members 170a' and 170b'. The retaining members 170a'and 170b' have associated semi-annular recesses and enlarged grippingportions which face toward the recess 178 of the illumination member144, with the retaining member gripping portions being received in therecess 178 when the clamp member 88 closes. Thus, the structure issimilar to the arrangement previously discussed in connection with theclamp member 80 with associated jaws and retaining members. Aspreviously indicated, the inflation nozzle 114 of the clamp member 80has an annular recess similar to the recess 178 associated with theillumination member 144 in order to receive the gripping portions of thejaw retaining members.

With further reference to FIG. 6, the clamp member 88 has an aircylinder 180 associated with the jaws 146a' and 146b', with the cylinder180 having a piston which may be extended to bear against the upper jawand close the jaws of the clamp 88 in a manner as previously discussedin connection with the clamp member 80. Thus, during operation of thedevice, an end of the elastic sleeve is received over the illuminationmember 144 intermediate the open jaws 146a' and 146b', after which thejaws are closed by the cylinder 180 while the retaining members 170a'and 170b' sealingly engage the balloon end against the illuminationmember 144 in a closure position of the clamp member 88. After both theclamp members 80 and 88 have been closed about the sleeve, air is passedthrough the inflation nozzle 114 associated with the clamp member 80 inorder to inflate the balloon and permit testing of the balloon. Inaddition, at this time, light is transmitted by the transmitting member90 from the light source to the illumination member 144 within theinflated balloon in order to illuminate the ballon from the insidethrough the walls of the inflated balloon.

With reference to FIGS. 1 and 7, the apparatus 20 has a base plate 182which separates the test assembly 44 from a drive assembly 184 which ismounted beneath the plate 182. The apparatus 20 has a pair of spacedbearings 186 and 188 mounted on the base plate 182, and supporting afirst shaft 190 which is associated with the first support member 46,with the shaft 190 being slidably and rotatably received in theassociated bearings 186 and 188. The apparatus 20 has a pair ofadditional bearings 192 and 194 mounted on the plate 182 and supportinga second shaft 196 associated with the second support member 48, withthe second shaft 196 being slidably and rotatably received within thebearings 192 and 194. As shown, a lower end 198 of the upright arm 56associated with the first support member 46 is fixedly attached to thefirst shaft 190 intermediate the bearings 186 and 188 by suitable means,such as a screw 200. Similarly, a lower end 202 of the upright arm 50associated with the second support member 48 is fixedly attached to thesecond shaft 196 intermediate the bearings 192 and 194 by suitablemeans, such as a screw 204.

With reference to FIGS. 1, 3, and 7, the first and seccond shafts 190and 196 have a pair of adjacent ends 206 and 208, respectively, defininga pair of overlapping semi-cylindrical tongues 210 and 212, with thetongues 210 and 212 defining respective planar surfaces 214 and 216which face each other intermediate the tongues 210 and 212. As will beapparent, the tongues 210 and 212 of the associated first and secondshafts 190 and 196 permit sliding movement of the shafts 190 and 196relative to each other through the associated bearings. In addition, thetongues 210 and 212 of the respective shafts 190 and 196 cooperate toimpart rotational movement from either of the shafts 190 or 196 to theother shaft 190 or 196, such that the shafts rotate together as a unit,although the shafts 190 and 196 may independently undertake relativelongitudinal sliding movement through the associated bearings.

Since the lower end 198 of the arm 56 associated with the first supportmember 46 is attached to the shaft 190, while the lower end 202 of thearm 50 associated with the second support member 48 is secured to thesecond shaft 196, both the first and second support members 46 and 48are permitted to rotate as a unit about the longitudinal axis of thefirst and second shafts 190 and 196. In this regard, it has beenpreviously noted that the shaft 62 maintains the first and secondsupport member 46 and 48 in an aligned configuration, such that theshaft 62 adds stability to the test assembly 44 as the first and secondsupport members 46 and 48 rotate together with the first and secondshafts 190 and 196 in the respective bearings. In addition, since thefirst and second shafts 190 and 196 are slidably received in theassociated bearings, and since the tongues 210 and 212 permit slidingmovement of the shafts relative to each other, it will be apparent thatthe apparatus permits relative longitudinal movement of the first andsecond support members 46 and 48 toward and away from each other. Inthis regard, it has previously been noted that the shaft 62 is slidablyreceived in the second support member 48, while the crank shaft 66 isslidably received in the crank member 68 to permit movement of thesupport members 46 and 48 relative to each other. Of course, the clampmembers 80 and 88 move toward and away from each other responsive tolongitudinal movement of the associated first and second support members46 and 48.

With reference to FIGS. 1 and 7, the apparatus 20 has a drive assembly217 for the first support member 46 having a pair of spaced bearings 218and 220 which depend from the base plate 182 and which support andslidably receive a third shaft 222. The drive assembly 217 also has adrive shaft 224 having a lower end 226 fixedly secured to the thirdshaft 222. As shown, the drive shaft 224 projects upwardly from thethird shaft 222 through an elongated slot 228 in the base plate 182. Thefirst shaft 190 has a pulley member 230 fixedly secured to the shaft 190and having a pair of spaced annular flanges 232 defining an annulargroove 234. The drive shaft 224 has a forked upper end 236 defining apair of spaced tines which are received in the groove 234 on opposedsides of the pulley member 230, such that the pulley member 230 ispermitted to rotate within the tines of the drive shaft 224 while thepulley member 230 maintains the drive shaft 224 in an upright position.The drive apparatus 217 also has a cylinder 238 which is mounted belowthe base plate 182, with the cylinder 238 having a piston 240 which hasits outer end 242 secured to the drive shaft 224. The cylinder 238 has apair of air supply lines 244 and 246 which control operation of thecylinder 238. Thus, when the piston 240 extends and retracts relative tothe cylinder 238, motion of the piston 240 is translated through thedrive shaft 224 to the pulley member 230 on the first shaft 190. Sincethe pulley member 230 is fixedly secured to the shaft 190, the pistonmotion of cylinder 238 is further translated to the first shaft 190 andthe first support member 46 of the test assembly 44 which is fixedlysecured to the shaft 190. Accordingly, the cylinder 238 is utilized todrive the first support member 46 and associated clamp member 80 in alongitudinal direction relative to the base plate 182. As previouslyindicated, the drive shaft 224 associated with the cylinder 238 does notimpede rotational movement of the first shaft 190 and the first supportmember 46 of the test assembly 44.

The drive assembly 217 has a first control switch 248 which is mountedbeneath the base plate 182 in a suitable manner. The lower end 226 ofthe drive shaft 224 has a lower plate 250 which contacts the switch 248in an extended configuration of the piston 240 associated with thecylinder 238. The drive assembly 217 also has a second control switch252 which is mounted in a suitable manner beneath the base plate 182. Asshown, the drive shaft 224 has a depending control plate 254 having athreaded bolt 256 received in a threaded aperture in the plate 254 andaligned with the switch 252. Thus, a forward end 258 of the bolt 256which projects through the plate 254 contacts the switch 252 in anextended configuration of the cylinder piston 240. Of course, the bolt256 may be adjusted in the plate 254 to obtain closure of the switch 252at a desired extended position of the piston 240. The drive assembly 217also has a third control switch 260 which may be mounted in a suitablemanner beneath the base plate 182. As shown, the assembly 217 has athreaded bolt 262 which extends through a threaded aperture in thecontrol plate 254 with the bolt 262 being aligned with the switch 260,such that an outer end 264 of the bolt 262 contacts and actuates theswitch 260 in a retracted position of the piston 240 within the cylinder238. The position of the bolt 262 may be adjusted in the plate 254 inorder to select the retracted position of the piston 240 at which thethird switch 260 actuates. Thus, the cylinder 238 of the drive assembly217 is utilized to move the first support member 46 of the test assembly44, while the control switches 248, 252, and 260 determine extended andretracted positions of the piston 240 in the cylinder 238 for purposesof control.

The apparatus 20 also has a drive assembly generally designated 266 forcontrolling movement of the second support member 48 of the testassembly 44. The drive assembly 266 has a pair of spaced bearings 268and 270 depending from the base plate 182 and slidably receiving afourth shaft 272 beneath the plate 182. The drive assembly 266 has adrive shaft 274 having a lower end 276 fixedly secured to the fourthshaft 272, with the drive shaft 274 projecting upwardly throughelongated slot 278 in the base plate 182. The second shaft 196 has apulley member 280 fixedly secured to the shaft 196, and having a pair ofspaced annular flanges 282 defining an annular groove 284 intermediatethe flanges 282. The drive shaft 274 has a forked upper end 286 defininga pair of spaced tines which are received in the groove 284 on opposedsides of the pulley member 280, such that the pulley member 280 ispermitted to rotate between the tines of the drive shaft 274 while thepulley member 280 maintains the drive shaft 274 in an upright position.Thus, the drive shaft 274 carries the pulley member 280 and associatedsecond shaft 196, although the pulley member 280 and shaft 196 arepermitted to rotate in the associated bearings such that the drive shaft274 does not impede rotational movement of the second support member 48of the test assembly 44.

The drive assembly 266 has a cylinder 288 which is mounted in a suitablemanner beneath the base plate 182. As shown, the cylinder 288 has anextensible piston 290 having an outer end 292 secured to a lower end 276of the drive shaft 274. The cylinder 288 has a pair of air supply lines294 and 296 which are utilized to control the cylinder 288 and movementof the associated piston 290. Thus, longitudinal motion of the piston290 relative to the cylinder 288 is translated through the drive shaft274 to the pulley member 280 and the second shaft 196, since the pulleymember 280 is fixedly secured to the shaft 196. In turn, longitudinalmotion of the second shaft 196 is translated through the upper arm 50,which is secured to the shaft 196, to the second support member 48 andthe associated clamp member 88 of the test assembly 44. In this manner,the cylinder 288 is utilized to move the second support member 48 of thetest assembly 44 in a longitudinal direction along the base plate 182and relative to the first support member 46 of the test assembly 44.

The drive assembly 266 has a fourth control switch 298 which may bemounted in a suitable manner beneath the base plate 182. The driveassembly 266 also has a control plate 300 which is secured to anddepends from the drive shaft 274. As shown, a threaded bolt 302 isreceived in a suitable threaded aperture in the plate 300 at a positionaligned with the control switch 298. A forward end 304 of the bolt 302contacts and actuates the switch 298 in an extended position of thecylinder piston 290. Thus, the cylinder 288 of the drive assembly 266 isutilized to move the second support member 48 of the test assembly 44relative to the first support member 46 while the switch 298 is utilizedto control the drive assembly 266.

The apparatus 20 also has a limit assembly generally designated 306associated with the drive assembly 266. The limit assembly 306 comprisesa cylinder 308 which may be mounted in a suitable manner beneath thebase plate 182. The cylinder 308 has a piston 310 which may be extendedfrom the cylinder 308, with the piston 310 having an abutment member 312secured to an outer end of the piston 310. The abutment member 312 ispositioned to strike the control plate 300 of the drive shaft 274 at aposition behind the bolt 302. During operation of the device, thecylinder 308 is operated by a suitable air supply line to extend thepiston 310 and position the abutment member 312 to stop rearwardmovement of the control plate 300 and the piston 290 as the piston 290retracts within the cylinder 288 of the drive assembly 266. Thus, thecylinder 308 effectively operates to limit motion of the second supportmember 48 in a right hand direction along the base plate, as viewed inFIG. 1.

Referring now to FIGS. 1 and 2, the apparatus 20 has a constant tensioncontrol device or negator motor generally designated 314, such as adevice model No. ML-2921 sold by Ametek/Hunter Spring, Hatfield, Pa.,which acts as a counterbalance during rotational movement of the testassembly 44. The tension control device 314 comprises a pair of spools316 and 318 which are rotatably mounted on a plate 320 behind thespools. As shown, the apparatus 20 has an upright plate 324 positionedbehind the test assembly 44, with the plate 320 of the control device314 being mounted on the rear side of plate 324 which is interposedbetween the control device 314 and the test assembly 44. The controldevice 314 also has a control spool 322 which is rotatably mounted onthe plate 320 intermediate the spools 316 and 318 and the upright plate324. The spools 316 and 318 have elongated strips 326 and 328 of asuitable metallic material which are separately wound about the spools316 and 318, and which are wound together about the spool 322. Thecontrol device 314 also have a wire or cord 330 having one end woundabout the control spool 322, with the cord 330 extending throughsuitable openings in the control device 314 and plate 324 to the testassembly 44, where an outer end of the cord 330 is attached to the shaft62 by a suitable hook 332.

The control device 314 operates in association with the test assembly 44as follows. The control device 314 applies force against the cord 330 inorder to maintain the first and second support members 46 and 48 of thetest assembly 44 in a normal upright configuration, as illustrated inFIGS. 1 and 2. However, when it is decided to rotate the test assembly44 as a unit in a forward direction as viewed in FIG. 1, and in acounter-clockwise direction as viewed in FIG. 2, the control device 314applies a constant force against the cord 330 and the test assembly 44during rotation of the test assembly 44 due to cooperation of themetallic strips 326 and 328 and the control device spools. Thus, thecontrol device 314 prevents the test assembly 44 from falling from itsnormal upright position, and permits rotational movement of the testassembly 44 about the rotational axes of the first and second shafts 190and 196 while the operator moves the test assembly under uniform tensionsupplied by the cord 330.

Accordingly, after the balloon has been suitably inflated in the clampmembers 80 and 88, the operator may rotate the test assembly 44including the first and second support members 46 and 48 along with theinflated balloon toward the tray 40 shown in FIG. 1. The test assembly44 may be rotated a sufficient distance in order to position theinflated balloon within the liquid L retained in the tray cavity 42,such that the inflated balloon may be submerged below the surface of theliquid L during testing. Thus, the operator may readily ascertainpossible leakage of air from the submerged balloon through visualinspection for air bubbles which rise from the leaking balloon to thesurface of the liquid L. Once this test has been completed, the operatormay move the test assembly 44 to its upright position where the controldevice 314 again maintains the first and second support members 46 and48 of the test assembly 44 in the normal upright configuration.

As shown in FIG. 2, the second support member 48 of the test assembly 44has an inclined block 334 which is secured to the upright arm 50 with anouter end 336 of the block 334 projecting forwardly from the secondsupport member 48. When the test assembly 44 is moved from its normalfirst upright position to the second forward position with the inflatedballoon and clamp members 80 and 88 submerged in the tray liquid L, theouter end 336 of block 334 strikes the upper surface of the base plate182 to limit movement of the test assembly 44 at the second submergedposition. Thus, the control device 314 acts as a counterbalance for thetest assembly 44 to permit movement of the test assembly 44 from itsupright position to the submerged position until the block 334 strikesthe base plate 182 when the test assembly 44 assumes the submergedposition. The test assembly 44 may be maintained in this configurationwithout further pulling of the test assembly by the operator until adetermination of possible leakage from the inflated balloon has beencompleted, after which the operator may return the test assembly 44 fromthe submerged position to its normal upright configuration.

Control of the device 20 will first be described in connection with thediagrammatic view of FIG. 8. As shown, the testing apparatus 20 has asuitable air supply 338 which is utilized in conjunction with thevarious cylinders previously described. The apparatus 20 also has acontrol system 340 which is utilized to control operation of the deviceduring testing, and it will be further described in connection with FIG.11. The control system 340 may be constructed in any suitable mannersuch as in the form of a fluidic circuit, associated with the air supply338 and the described air cylinders. However, for convenience, thecontrol system 340 will be described in the form of an electricalcircuit which is utilized to actuate switches or solenoids associatedwith the cylinders for control of the device.

With reference to FIGS. 1 and 8, when it is desired to initiateoperation of the device, the switch 28 is moved to the closed positionin order to connect power from the power supply 342 to the controlsystem 340 and initialize the circuit. At this time, the jaws of bothclamp members 80 and 88 are in an open position, and the clamp members80 and 88 are spaced from each other a distance substantially greaterthan the length of the balloon to be tested. Next, the operator placesone end of the sleeve or balloon on the inflation nozzle 114 of theclamp member 80 in a position with the sleeve end located intermediatethe elastic retaining members 170a and 170b of the clamp member 80. Asshown, the separate start switches 30 are connected in series to thecontrol system 340. Thus, the device requires simultaneous actuation ofboth switches 30 to initiate operation of the control system 340, andthe switches are placed at spaced locations in order to assure that theoperator must use both hands to start the device, such that the operatormust remove both hands from the clamp members 80 and 88 as a safetyprecaution.

Once the start switches 30 have been properly depressed by the operator,the control system 340 actuates a switch or solenoid 346 over a line 348in order to connect air from the air supply 338 through a supply line350 to the cylinder 164. In turn, the piston 166 extends from thecylinder 164 and causes closure of the jaws 146a and 146b of theinflation clamp member 80, such that the jaws engage the balloon end insealing engagement against the inflation nozzle 114 within the jaws.

With reference to FIGS. 1, 7, and 8, after a delay during which theclamp member 80 closes, the control system 340 then actuates a solenoidor switch 352 over a line 354 in order to connect air from supply 338through line 296 to the two-way cylinder 288 of the drive assembly 266.In turn, the piston 290 of cylinder 288 extends, and moves the driveshaft 274 and associated illumination clamp member 88 toward theballoon. In a forward position of the cylinder piston 290 and the clampmember 88, the illumination member 144 of the clamp member 88 enters theother end of the balloon after which the drive shaft 274 actuates theswitch 298 which signals the control system 340 over line 356 that theclamp member 88 is at the desired position relative to the balloon. Thecontrol system 340 then actuates a switch or solenoid 358 over line 360in order to connect the air supply 338 to the cylinder 180 associatedwith the clamp member 88. In turn, a piston 362 of the cylinder 180extends, and closes the jaws 146a' and 146b' of the clamp member 88 overthe balloon in sealing engagement against the illumination member 144.

After a delay during which the clamp member 88 closes, the controlsystem 340 actuates a switch or solenoid 364 over the line 366 in orderto connect the air supply 338 through line 246 to the two-way cylinder238 of the drive system 217. In turn, the cylinder piston 240 extendsfrom the cylinder 238, and moves the drive shaft 224 and associatedclamp member 80 in a direction toward the actuation nozzle 108. When theconnection member 82 and associated valve assembly 112 are located atthe desired position with the actuation nozzle 108 received within andopening the valve assembly 112, the drive shaft 224 strikes the switches248 and 252 which signal the control system 340 over respective lines367 and 369. In response to the switch 252, the control system 340signals a switch or solenoid 368 over line 370 in order to connect anadjustable air control cylinder 372 associated with the air supply 338to the actuation nozzle 108. A predetermined amount of air passes fromthe control cylinder 372 through the actuation nozzle 108, the openvalve assembly 112 of the connection member 82, and through theinflation nozzle 114 into the balloon. The control cylinder 372 may beadjusted, as desired, in order to retain a selected amount of air whichis utilized to inflate the balloon. As a result, the balloon, which isretained in the closed clamp members 80 and 88, is inflated to anenlarged configuration after which the passage of air from cylinder 372through the actuation nozzle 108 ceases. At this time, the balloon is inan inflated configuration suitable for testing, as shown in FIG. 10. Thecontrol system 340 also actuates a valve or solenoid 376 over line 378in order to connect the cylinder 308 of the limit assembly 306 to theair supply 338. In turn, the piston 310 and associated abutment member312 extends a predetermined amount from the cylinder 308.

The signal from actuated switch 248 over line 267 initiates a timer inthe control system 340 which times out after the balloon has beeninflated and the piston 310 of cylinder 308 has extended. Referring toFIGS. 1, 7, and 8, after the timer times out, the control system 340then signals the valve or solenoid 364 over line 366 in order to connectthe air supply through line 244 to the cylinder 238 and cause retractionof the piston 240 into the cylinder 238. As a result, the piston 240moves the drive shaft 224 and the associated clamp member 80 away fromthe actuation nozzle 108 until the valve assembly 112 closes, and thevalve assembly 112 is free of obstruction from the actuation nozzle 108.At this time, the control plate of the drive shaft 224 strikes theswitch 260 which signals the control system 340 over line 374. Also, thecylinder 238 stops movement of the piston 240, the drive shaft 244, andthe associated clamp member 80 with the valve assembly 112 of theconnection member 82 free from the actuation nozzle 108 to permitsubsequent rotation of the test assembly 44. Since the valve assembly112 has been closed, the balloon is maintained by the clamp members 80and 88 in an inflated configuration during the subsequent testing.

When the timer times out, the control system 340 also actuates thesolenoid or switch 352 in order to connect the air supply through line294 of the cylinder 288 and cause retraction of the piston 290. As aresult, the piston moves the drive shaft 274 and associated clamp member88 in a direction away from the clamp member 80 after it has stopped.Accordingly, the piston 290 retracts into the cylinder 288 until thecontrol plate on the drive shaft 274 stikes the extended abutment member312 in order to stop and limit retraction of the piston 290 into thecylinder 288. In this configuration, the stationary clamp members 80 and88 are located at a desired spacing relative to each other in order totest the inflated balloon. The control system 340 energizes the lightsource 140 over line 378 in order to cause passage of light through thelight transmitting member 90 to the illumination member 144. Of course,the light source may be continuously energized, if desired. Aspreviously indicated, the illumination member 144 supplies light fromthe interior of the balloon through the walls of the balloon in order topermit clear visual inspection of the expanded balloon walls, such thatthe operator may readily determine whether imperfections exist in theballoon, such as areas of weakness, or dirt particles on the inside ofthe balloon. With reference to FIGS. 1 and 2, the operator may utilizethe handle 78 in order to simultaneously rotate the clamp members 80 and88, as well as the inflated balloon, while the illumination member 144continuously illuminates the balloon walls from the inside of theballoon. In this manner, the operator may visually inspect the expandedballoon walls circumferentially around the balloon while rotating theclamp members 80 and 88 through use of the handle 78.

Next, the operator may move the test assembly 44 from its first uprightposition to its second submerged position where the inflated balloon islocated below the surface of the liquid L in the tray 40, and the block334 on the second support member 48 stops forward movement of the testassembly at the submerged position. In the event that the ballooncontains imperfections such as pin holes, air quickly passes through theballoon walls, and forms bubbles which may be visually ascertained atthe surface of the liquid L. Accordingly, the operator may readilydetermine whether the balloon has such defects, after which the testassembly 44 may be raised to its upright configuration at which time thetesting has been completed.

If the balloon was found to be in an acceptable condition for securementon a catheter shaft, i.e., the balloon did not have imperfections, theoperator then presses the accept switch 34 which signals the controlsystem 340 that testing has been completed, and also increments thedigital accept counter 38. In the event that the balloon containeddefects, the operator depresses the reject switch 32 which signals thecontrol system 340 that testing has been completed, and also incrementsthe digital reject counter 36. Thus, the apparatus 20 maintains arunning count of the accepted and rejected balloons through use of thecounters 38 and 36 in association with the switches 34 and 32.

After the control system 340 has been signaled by one of the accept orreject switches 34 or 32, the control system 340 signals the switches orsolenoids 346 and 358 associated with the cylinders 164 and 180,respectively. In turn, the associated spring biased plungers 166 and 362retract, and the respective clamp members 80 and 88 open and release thetested balloon. Also, the control system 340 signals the switch orsolenoid 376 to retract the spring biased piston 310 into the cylinder308 and withdraw the abutment member 312 away from the control plate ofthe drive shaft 274. As a result, the cylinder 288 retracts the piston290 into the cylinder 288 causing movement of the drive shaft 274 andassociated clamp member 88 away from the clamp member 80 until the clampmember 88 reaches the desired position spaced from the clamp member 80 adistance substantially greater than the length of the balloon. At thistime, movement of the drive shaft 274 and the clamp member 88 hasceased, and the clamp members 80 and 88 are located at the finalposition with the clamp members 80 and 88 in an open position disengagedfrom the balloon. Thus, the operator may remove the tested balloon fromone of the clamp members 80 or 88, and may discard the balloon if it hasbeen found defective or may retain the balloon for subsequent use iffound in an acceptable condition. After removal of the balloon, theclamp members 80 and 88 are located in a proper spaced and openconfiguration for immediately testing a subsequent balloon.

The circuitry for the control system 340 is described in more detail inconnection with FIG. 11. As shown, the power supply Vcc may be connectedto the on-off switch 28. When the switch 28 is closed, a pulse circuitryP1, such as a differentiator circuit, generates a pulse as the resetsignal R which is connected through the OR gates OR1, OR2, OR3, OR4,OR5, OR6, and OR7 to various flip flops in the circuit in order to resetthe flip flops.

When both start switches 30 are closed, the pulse circuitry P2 generatesa pulse which sets flip flop ff1. In turn, the flip flop ff1 signals thesolenoid 346 at the Q output of the flip flop which causes closure ofthe clamp member 80. Also, the pulse from the pulse circuitry P2triggers the single-shot SS1 which undertakes a delay associated withthe time required for closure of the clamp member 80. When thesingle-shot SS1 times out, the pulse circuitry P3 generates a pulsewhich sets flip flop ff2 and signals solenoid 352 at the Q output tomove the clamp member 88 toward the clamp member 80.

As shown, the switch 298 is connected as an input of an inverter I1, andthe output of the inverter is connected as an input to AND gate A1.Also, the Q output of flip flop of ff2 is connected as an input to theAND gate A1, such that the signals from the set flip flop ff2 and switch298, when closed, pass through the AND gate A1 and cause the pulsecircuitry P4 to generate a pulse. In turn, the pulse from pulsecircuitry P4 sets the flip flop ff3 which signals the solenoid 358 atits Q output to cause closure of the clamp member 88 when the clampmember has been properly positioned relative to the balloon. Inaddition, the pulse from the pulse circuitry P4 triggers the single-shotSS2 which undertakes a delay to assure closure of the clamp member 88.When the single-shot SS2 times out, the pulse circuitry P5 generates apulse and sets the flip flop ff4. The flip flop ff4 then signals thesolenoid 364 at its Q output to cause movement of the clamp member 80toward the left, as viewed in FIG. 1.

With reference to FIG. 11, the switch 252 is connected as an input tothe inverter I2, and the output of the inverter I2 is connected as aninput to the AND gate A2. In addition, the Q output of the flip flop ff4is connected as an input to the AND gate A2, such that signals from theset flip flop ff4 and the actuated switch 252 pass through the AND gateA2 and cause the pulse circuitry P6 to generate a pulse. The pulse frompulse circuitry P6 sets the flip flop ff5 which signals the solenoid 368at its Q output in order to cause inflation of the retained balloon.Also, the pulse from pulse circuitry P6 sets the flip flop ff6 whichsignals the solenoid 376 and causes extension of the associated cylinderpiston in order to limit movement of the clamp member 88.

The switch 248 is connected as an input to the inverter I3, and theoutput of the inverter I3 is connected as an input to the AND gate A3.Also, the Q output of flip flop ff6 is connected as an input to the ANDgate A3, such that the signals from the set flip flop ff6 and the switch248, when closed, cause the single-shot SS3 to undertake a delay whichis sufficiently long to assure that the balloon has been inflated andthat the piston cylinder associated with the solenoid 376 has extendedthe desired amount. When the single-shot SS3 times out, the pulsecircuitry P7 generates a pulse, and sets the flip flop ff7. In turn, theflip flop ff7 causes energization of the light source 140 preparatory totesting of the balloon. Also, the pulse from the pulse circuitry P7resets the flip flop ff5 associated with the solenoid 368 through ORgate OR5. The pulse from pulse circuitry P7 is further connected throughOR gate OR4 to the flip flop ff4, and resets the flip flop ff4associated with the solenoid 364 to cause movement of the clamp member80 in a reverse direction after inflation of the balloon. In addition,the pulse from pulse circuitry P7 is connected to the flip flop ff2through OR gate OR 2, and resets the flip flop ff2 associated with thesolenoid 352 to cause movement of the clamp member 88 in a directiontoward the right, as viewed in FIG. 1.

With reference to FIG. 11, the switch 260 is connected as an input tothe inverter I4, and the output of the inverter I4 is connected as aninput to the AND gate A4. Also, the Q output of the flip flop ff7 isconnected as an input to the AND gate A4, such that the signals from theset flip flop ff7 and the switch 260, when closed responsive toretraction of the clamp member 80, result in a signal through the ANDgate A4 to an input of the AND gate A5. At this time, the clamp members80 and 88 are at the proper position with the balloon retained in aninflated condition to permit testing by the operator.

When testing of the balloon has been completed, the operator depressesone of the accept or reject switches 34 or 32. As shown, the powersource Vcc is connected to both switches 34 and 32. Thus, if the switch34 is closed, a signal from switch 34 passes through the OR gate OR8 tothe other input of the AND gate A5. In addition, the closed switch 34causes the pulse circuitry P8 to generate a pulse and increment theaccept counter 38. However, if the switch 32 is closed, a signal fromthe switch 32 passes through the OR gate OR8 to the second input of theAND gate A5. Also, the closed switch 32 causes the pulse circuitry P9 togenerate a pulse and increment the reject counter 36. Thus, once theswitch 260 has closed, and one of the two switches 34 and 32 has beenclosed by the operator, a signal is formed at the output of the AND gateA5, and causes the pulse circuitry P10 to generate a pulse.

As shown, the pulse circuitry P10 is connected to the flip flop ff7through OR gate OR7, such that the pulse from pulse circuitry P10 resetsthe flip flop ff7 and causes deenergization of the light source 140.Also, the pulse circuitry P10 resets the flip flop ff6 through OR gateOR6, and causes the cylinder piston associated with the solenoid 376 toretract and permit movement of the clamp member 88 to its finalposition. Further, the pulse circuitry P10 is connected to the flip flopff3 through the OR gate OR3, such that the pulse from pulse circuitryP10 resets the flip flop ff3. In turn, the flip flop ff3 signals thesolenoid 358, and causes the clamp member 88 to open. In addition, thepulse circuitry P10 is connected to the flip flop ff1 through the ORgate OR1, and the pulse from the pulse circuitry P10 resets the flipflop ff1, such that the associated solenoid 346 causes the clamp member80 to open. At this time, the clamp member 88 has undertaken movement toits final position, and both the clamp members 80 and 88 have beensignalled to open. Once the clamp members 80 and 88 are fully open, theoperator may remove the tested sleeve for appropriate dispositiondepending upon the testing results. In this configuration of the controlsystem 340, the flip flops have all been reset in preparation fortesting of a subsequent sleeve, which may be initiated through use ofthe start switches 30.

Thus, in accordance with the present invention, the apparatus 20 permitstesting of a balloon in a simplified manner to determine whether theballoon has imperfections which would prevent its use on a catheter. Thedevice automatically inflates the balloon, and illuminates the walls ofthe balloon from the inside of the balloon while the balloon is rotatedto permit visual inspection of the balloon walls. Further, the inflatedballoon may be submerged in a testing liquid to determine whether theballoon contains additional imperfections, such as pin holes. Theapparatus may also be utilized to determine a total count of theaccepted and rejected balloons. The defective balloons may be discarded,and acceptable balloons may be secured onto the catheter shafts. Thus,imperfections in the balloon may be determined prior to securement ontothe catheter shaft, and the device minimizes the possibility that acatheter must be discarded due to discovery of an imperfection in theballoon after securement onto the shaft. The apparatus of the presentinvention permits testing of balloons in a simplified and efficientmanner, and eliminates waste associated with catheters which must bediscarded due to a defective balloon only discovered after the balloonhas been secured onto the catheter shaft.

The foregoing detailed description is given for clearness ofunderstanding only, and no unnecessary limitations should be understoodtherefrom, as modifications will be obvious to those skilled in the art.

I claim:
 1. A device for testing an elongated hollow elastic sleevehaving a pair of opposed ends, comprising:means for releasably retainingand closing the opposed ends of the sleeve; means for inflating acentral portion of the sleeve intermediate its ends; means forilluminating walls of the inflated sleeve from within the sleeve; meansfor rotating the retaining means and inflated sleeve for inspectionthereof; means for retaining a testing liquid; and means for selectivelysubmerging the inflated sleeve into the testing liquid.
 2. The device ofclaim 1 including means for rotating the retaining means and inflatedsleeve.
 3. The device of claim 1 wherein the retaining means comprisesclamp means for selectively gripping one end of the sleeve.
 4. Thedevice of claim 3 wherein the clamp means comprises a support member toreceive one end of the sleeve, and a pair of jaws on opposed sides ofthe support member, and including means for selectively moving the jawsbetween a first open position with the jaws spaced from the supportmember, and a second closed position with the jaws gripping the sleeveagainst the support member.
 5. The device of claim 4 wherein said jawsinclude a pair of elastic retaining members having recesses facing thesupport member for engaging the sleeve on opposed sides of the supportmember.
 6. The device of claim 4 wherein the support member comprises anelongated inflation member having an orifice adjacent an outer endpositioned within the sleeve when the sleeve is positioned on theinflation member, and a passageway communicating with the orifice. 7.The device of claim 6 including means for initiating the jaw movingmeans to move the jaws from said open to closed position after placementof the sleeve on the inflation member, and means for initiating theinflating means responsive to closure of the jaws on the sleeve.
 8. Thedevice of claim 7 including means for initiating the jaw moving means tomove the jaws from said closed to open position subsequent to testing ofthe sleeve.
 9. The device of claim 1 wherein the inflating meansincludes means for selecting a predetermined amount of gas for inflatingthe sleeve.
 10. The device of claim 9 including means for adjusting theselecting means to modify the amount of predetermined gas.
 11. Thedevice of claim 1 including means for separately counting acceptable anddefective tested sleeves.
 12. A device for testing an elongated elasticsleeve having a pair of opposed ends, comprising:first retaining meanscomprising an elongated inflation member to receive one end of thesleeve, with said inflation member having an orifice communicating withthe inside of the sleeve when the sleeve is placed on the inflationmember and having a passageway communicating with the orifice, and afirst clamp member having a pair of opposed movable jaws on opposedsides of the inflation member; first means for selectively moving thejaws of the first clamp member between a first open position with thejaws spaced from the inflation member, and a second closed position withthe jaws gripping the sleeve against the inflation member; secondretaining means comprising an elongated support member to receive theother end of the sleeve, and a second clamp member having a pair ofopposed movable jaws on opposed sides of the support member; secondmeans for selectively moving the jaws of the second clamp member betweena first open position with the jaws spaced from the support member, anda second closed position with the jaws gripping the sleeve against thesupport member; means for selectively inflating the sleeve through thepassageway of said inflation member; first means for rotatablysupporting the first clamp member about an axis; second means forrotatably supporting the second clamp member about said axis; and meansfor simultaneously rotating the first and second clamp members aboutsaid axis.
 13. The device of claim 12 wherein the first and secondsupport means support the inflation and support members generallyaligned with said rotation axis.
 14. The device of claim 12 includingfirst means for supporting the first clamp member, and second means forsupporting the second clamp member with the second clamp member spacedfrom the first clamp member, and with the support member generallyaligned with the inflation member.
 15. The device of claim 14 includingfirst drive means for moving the first supporting means and modifyingthe distance between the first and second clamp members, and seconddrive means for moving the second supporting means and modifying thedistance between the first and second clamp members.
 16. The device ofclaim 12 including frame means comprising first means for supporting thefirst retaining means, second means for supporting the second retainingmeans, and means for pivotally mounting the first and second supportingmeans to permit movement of the first and second clamp members between afirst testing position and a second testing position spaced from thefirst position.
 17. The device of claim 16 including means for retaininga testing liquid, and in which the first and second clamp members arespaced from the testing liquid at said first testing position and aresubmerged in the testing liquid at said second testing position.
 18. Thedevice of claim 12 including means for retaining a testing liquid, andmeans for selectively submerging the inflated sleeve into the liquid.19. A device for testing an elongated elastic sleeve having a pair ofopposed ends, comprising:means for releasably retaining the opposed endsof the sleeve, said retaining means comprising clamp means forselectively gripping one end of the sleeve, said clamp means comprisinga support member to receive one end of the sleeve, and a pair of jaws onopposed sides of the support member, and including means for selectivelymoving the jaws between a first open position with the jaws spaced fromthe support member, and a second closed position with the jaws grippingthe sleeve against the support member, said jaws including a pair ofelastic retaining members having recesses facing the support member forengaging the sleeve on opposed sides of the support member, with saidretaining members including enlarged semi-annular gripping portionsfacing the support member, and in which the support member includes anannular groove to receive said gripping portions on opposed sides of thesupport member; and means for inflating a central portion of the sleeveintermediate its ends.
 20. A device for testing an elongated elasticsleeve having a pair of opposed ends, comprising:means for releasablyretaining the opposed ends of the sleeve, said retaining meanscomprising clamp means for selectively gripping one end of the sleeve,said clamp means comprising a support member to receive one end of thesleeve, and a pair of jaws on opposed sides of the support member, andincluding means for selectively moving the jaws between a first openposition with the jaws spaced from the support member, and a secondclosed position with the jaws gripping the sleeve against the supportmember, said support member comprising an elongated illumination member;means for transmitting light to the illumination member; and means forinflating a central portion of the sleeve intermediate its ends.
 21. Thedevice of claim 20 wherein the illumination member has a tapered outerend positioned within the sleeve when the sleeve is placed on theillumination member.
 22. The device of claim 20 including means forinitiating the jaw moving means to move the jaws from said open toclosed position after placement of the sleeve on the illuminationmember, and means for initiating the jaw moving means to move the jawsfrom said closed to open position subsequent to testing of the sleeve.23. A device for testing an elongated elastic sleeve having a pair ofopposed ends, comprising:means for releasably retaining the opposed endsof the sleeve; means for inflating a central portion of the sleeveintermediate its ends; a pair of switch means spaced a sufficientdistance from each other to require the use of both hands forsimultaneous actuation thereof; and means responsive only tosimultaneous actuation of both switch means for initiating operation ofthe device.
 24. A device for testing an elongated elastic sleeve havinga pair of opposed ends, comprising:first retaining means comprising anelongated inflation member to receive one end of the sleeve, with saidinflation member having an orifice communicating with the inside of thesleeve when the sleeve is placed on the inflation member and having apassageway communicating with the orifice, and a first clamp memberhaving a pair of opposed movable jaws on opposed sides of the inflationmember; first means for selectively moving the jaws of the first clampmember between a first open position with the jaws spaced from theinflation member, and a second closed position with the jaws grippingthe sleeve against the inflation member; second retaining meanscomprising an elongated support member to receive the other end of thesleeve, said support member comprising an illumination member, and asecond clamp member having a pair of opposed movable jaws on opposedsides of the support member; second means for selectively moving thejaws of the second clamp member between a first open position with thejaws spaced from the support member, and a second closed position withthe jaws gripping the sleeve against the support member; means forselectively inflating the sleeve through the passageway of saidinflation member; and means for supplying light to the illuminationmember.
 25. A device for testing an elongated elastic sleeve having apair of opposed ends, comprising:first retaining means comprising anelongated inflation member to receive one end of the sleeve, with saidinflation member having an orifice communicating with the inside of thesleeve when the sleeve is placed on the inflation member and having apassageway communicating with the orifice, and a first clamp memberhaving a pair of opposed movable jaws on opposed sides of the inflationmember; first means for selectively moving the jaws of the first clampmember between a first open position with the jaws spaced from theinflation member, and a second closed position with the jaws grippingthe sleeve against the inflation member; second retaining meanscomprising an elongated support member to receive the other end of thesleeve, and a second clamp member having a pair of opposed movable jawson opposed sides of the support member; second means for selectivelymoving the jaws of the second clamp member between a first open positionwith the jaws spaced from the support member, and a second closedposition with the jaws gripping the sleeve against the support member;means for selectively inflating the sleeve through the passageway ofsaid inflation member; first means for supporting the first clampmember; second means for supporting the second clamp member with thesecond clamp member spaced from the first clamp member, and with thesupport member generally aligned with the inflation member; first drivemeans for moving the first supporting means and modifying the distancebetween the first and second clamp members; second drive means formoving the second supporting means and modifying the distance betweenthe first and second clamp members; means for initiating one of thefirst and second jaw moving means to move the jaws of the associatedclamp member from open to closed position and grip one end of thesleeve; means responsive to the jaw initiating means to initiate atleast one of the first and second drive means and modify the spacingbetween the inflation and support members from a distance greater thanthe length of the sleeve to a distance less than the length of thesleeve; and means responsive to the drive initiating means forinitiating the other of the first and second jaw moving means to movethe jaws of the associated clamp member from open to closed position andgrip the other end of the sleeve.
 26. The device of claim 25 includingmeans for initiating the inflating means responsive to closure of bothsaid first and second clamp members.
 27. The device of claim 15including means for initiating the first jaw moving means to move thejaws of the first clamp member from the open to closed position and gripone end of the sleeve after placement of said sleeve one end on theinflation member in the open position of the first clamp member.
 28. Adevice for testing an elongated elastic sleeve having a pair of opposedends, comprising:first retaining means comprising an elongated inflationmember to receive one end of the sleeve, with said inflation memberhaving an orifice communicating with the inside of the sleeve when thesleeve is placed on the inflation member and having a passagewaycommunicating with the orifice, and a first clamp member having a pairof opposed movable jaws on opposed sides of the inflation member; firstmeans for selectively moving the jaws of the first clamp member betweena first open position with the jaws spaced from the inflation member,and a second closed position with the jaws gripping the sleeve againstthe inflation member; second retaining means comprising an elongatedsupport member to receive the other end of the sleeve, and a secondclamp member having a pair of opposed movable jaws on opposed sides ofthe support member; second means for selectively moving the jaws of thesecond clamp member between a first open position with the jaws spacedfrom the support member, and a second closed position with the jawsgripping the sleeve against the support member; means for selectivelyinflating the sleeve through the passageway of said inflation member;first means for supporting the first clamp member; second means forsupporting the second clamp member with the second clamp member spacedfrom the first clamp member, and with the support member generallyaligned with the inflation member; first drive means for moving thefirst supporting means and modifying the distance between the first andsecond clamp members; second drive means for moving the secondsupporting means and modifying the distance between the first and secondclamp members; means for initiating the first jaw moving means to movethe jaws of the first clamp member from the open to closed position andgrip one end of the sleeve after placement of said sleeve one end on theinflation member in the open position of the first clamp member; andmeans for initiating the second drive means responsive to closure of thefirst clamp member for moving the second supporting means toward thefirst supporting means from a first position with the support memberspaced a distance from the other end of the sleeve and a second positionwith the support member received in said other end of the sleeve withthe jaws of the second clamp member in the open position.
 29. The deviceof claim 28 including means for initiating the second jaw moving meansat said second position to move the jaws of the second clamp member fromthe open to closed position and grip the other end of the sleeve. 30.The device of claim 29 including means for initiating the inflatingmeans after closure of the second clamp member to inflate the sleevewith a predetermined amount of gas.
 31. The device of claim 29 includingnormally closed valve means communicating with the passageway of theinflation member, means for actuating and opening the valve means, meansresponsive to closure of the first and second clamp members forinitiating the first drive means and moving the first support means froma first position with the valve means in a closed configuration toward asecond position with the actuating means opening the valve means, andfrom said second position to a third position with the valve means in aclosed configuration, and including means for initiating the inflatingmeans at said second position to pass a predetermined amount of gasthrough the valve means and inflation member to inflate the sleeve. 32.The device of claim 31 wherein the actuating means comprises a nozzlehaving a passageway and orifice communicating with the valve means atsaid second position of the first support means.
 33. The device of claim31 wherein the first drive means positions the first support means withthe valve means spaced from the actuating means at said first and thirdpositions of the first support means.
 34. The device of claim 30including means for initiating the first and second jaw moving means tomove the jaws of the associated first and second clamp members from theclosed to open position and release the sleeve after testing has beencompleted.
 35. The device of claim 34 including means for initiating atleast one of the first and second drive means to move the associatedsupport means to a position with the inflation and support membersspaced from each other a distance greater than the length of the sleeve.36. The device of claim 34 including means for initiating the seconddrive means to move the second support means and second clamp member toa position with the support member spaced from the inflation member adistance greater than the length of the sleeve.
 37. A device for testingan elongated elastic sleeve having a pair of opposed ends,comprising:first retaining means comprising an elongated inflationmember to receive one end of the sleeve, with said inflation memberhaving an orifice communicating with the inside of the sleeve when thesleeve is placed on the inflation member and having a passagewaycommunicating with the orifice, and a first clamp member having a pairof opposed movable jaws on opposed sides of the inflation member; firstmeans for selectively moving the jaws of the first clamp member betweena first open position with the jaws spaced from the inflation member,and a second closed position with the jaws gripping the sleeve againstthe inflation member; second retaining means comprising an elongatedsupport member to receive the other end of the sleeve, and a secondclamp member having a pair of opposed movable jaws on opposed sides ofthe support member; second means for selectively moving the jaws of thesecond clamp member between a first open position with the jaws spacedfrom the support member, and a second closed position with the jawsgripping the sleeve against the support member; means for selectivelyinflating the sleeve through the passageway of said inflation member;frame means comprising first means for supporting the first retainingmeans, second means for supporting the second retaining means, and meansfor pivotally mounting the first and second supporting means to permitmovement of the first and second clamp members between a first testingposition and a second testing position spaced from the first position;and means for applying a relatively constant force to the frame meansopposing movement between said first and second positions.
 38. A devicefor testing an elongated elastic sleeve having a pair of opposed ends,comprising:first retaining means comprising an elongated inflationmember to receive one end of the sleeve, with said inflation memberhaving an orifice communicating with the inside of the sleeve when thesleeve is placed on the inflation member and having a passagewaycommunicating with the orifice, and a first clamp member having a pairof opposed movable jaws on opposed sides of the inflation member; firstmeans for selectively moving the jaws of the first clamp member betweena first open position with the jaws spaced from the inflation member,and a second closed position with the jaws gripping the sleeve againstthe inflation member; second retaining means comprising an elongatedsupport member to receive the other end of the sleeve, and a secondclamp member having a pair of opposed movable jaws on opposed sides ofthe support member; second means for selectively moving the jaws of thesecond clamp member between a first open position with the jaws spacedfrom the support member, and a second closed position with the jawsgripping the sleeve against the support member; means for selectivelyinflating the sleeve through the passageway of said inflation member; aframe assembly comprising, first support means comprising a firstupright arm, and a first support arm extending from the first uprightarm and being inclined at an acute angle relative to said first uprightarm, with said inflation member and first clamp member being retained bya lower end of the first support arm, and second support means generallyaligned with the first support means and comprising a second uprightarm, and a second support arm extending from the second upright arm andbeing inclined at an acute angle relative to said second upright arm,with said support member and second clamp member being retained by alower end of said second support arm.
 39. The device of claim 38including means for pivotally mounting a lower end of said first andsecond upright arms to permit simultaneous movement of the first andsecond clamp members between a first testing position and a secondtesting position spaced from the first position.
 40. The device of claim38 including means for slidably mounting a lower end of the first andsecond upright arms to permit modification of the spacing between thefirst and second support means and the associated first and second clampmembers.
 41. The device of claim 38 including first means for pivotallymounting the inflation member and first clamp member in said lower endof the first support arm, second means for pivotally mounting thesupport member and second clamp member in said lower end of the secondsupport arm, and means for simultaneously rotating the first and secondclamp members.
 42. The device of claim 41 wherein the rotating meanscomprises, a first pulley member pivotally mounted in the lower end ofthe first support arm and connected to the first clamp member, a secondpulley member pivotally mounted in the first support arm and beingaligned with the first pulley member, first endless belt means passingaround said first and second pulley members, a third pulley memberpivotally mounted in the lower end of the second support arm andconnected to the second clamp member, a fourth pulley member pivotallymounted in the second support arm and being aligned with said second andthird pulley members, second endless belt means passing around the thirdand fourth pulley members, and shaft means connecting the second andfourth pulley members for simultaneously rotating the pulley members andassociated first and second clamp members.
 43. The device of claim 42including handle means connected to the shaft means.
 44. The device ofclaim 42 wherein the shaft means comprises an elongated hollow sleeveconnected to one of said second and fourth pulley members, with saidsleeve having an elongated slot, and a shaft connected to the other ofsaid second and fourth pulley members and having an outer end slidablyreceived in said sleeve, with the outer end of said shaft having anoutwardly directed pin received in said slot.